Taiwan FDA registration 382cc347be312359b0f75cf1ea480e8a

"ACRO" Legionella Urinary Antigen Rapid Test (Non-Sterile)

TW: "艾快露" 退伍軍人肺炎尿液抗原快速檢驗試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·ACRO BIOTECH. INC.·Registered Sep 26, 2016 – Sep 26, 2026Active
Registration details
Analysis ID
382cc347be312359b0f75cf1ea480e8a
License Form
Ministry of Health Medical Device Import No. 017030
Customs Code
DHA09401703000
Company information
Manufacturer
ACRO BIOTECH. INC.
Manufacturer Country
United States
Authorized Representative
Grand Marquis IVD CO., LTD.
Product details
Intended Use
Limit the management method of medical equipment Haemophilus serogenus (C.3300) first level identification range.
Product Type (Level 1)
C Immunology and microbiology devices
Product Type (Level 2)
C3300 Haemophilus serology
Import Information
Imported from abroad
Dates and status
Registration Date
Sep 26, 2016
Expiry Date
Sep 26, 2026
About this record

Access comprehensive regulatory information for "ACRO" Legionella Urinary Antigen Rapid Test (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 382cc347be312359b0f75cf1ea480e8a and manufactured by ACRO BIOTECH. INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

Free DatabasePowered by Pure Global AI89,000+ Devices